Leifeng.com learned that on October 11, the UKnow® intracranial aneurysm surgery planning software (hereinafter referred to as “UKnow®”) developed by Qianglian Zhichuang® was officially approved by the State Drug Administration for the Class III Registration Certificate for Innovative Medical Devices. It is the first Class III certificate for innovative medical devices of “AI + treatment” in China.
UKnow® is used for the display, segmentation, measurement and processing of three-dimensional tomographic images of X-ray angiography in patients with cerebrovascular disease, assisting doctors in the microcatheter path and shaping planning for aneurysm coil embolization during neurointerventional surgery.
Compared with traditional neurointerventional procedures, UKnow® can improve the one-time delivery rate of the microcatheter, shorten the delivery time of the microcatheter, reduce the probability of complications caused by the repeated push of the microcatheter during the operation to vascular stimulation, and reduce the X-ray radiation of doctors and patients. time.
According to the “China Stroke Center Report 2020”, stroke is the leading cause of death and disability among adults in my country, and the overall prevalence is on the rise and younger.
The prevalence of aneurysm in Chinese adults is about 7%, which is much higher than 2-5% in Europe and the United States. There are tens of millions of patients with unruptured aneurysms in my country. Intracranial aneurysm is one of the important causes of hemorrhagic stroke. Once ruptured and hemorrhage, the mortality and disability rate is as high as 60.2-73.3%, and there is a high risk of rebleeding. The mortality rate of rebleeding is over 50%.
According to the “Guidelines for Diagnosis and Treatment of Intracranial Ruptured Aneurysms in China 2021”, interventional therapy is the preferred treatment method. However, due to the complex anatomical structure of cerebral blood vessels, the operation of neurointerventional surgery is very difficult.
In the interventional operation of intracranial aneurysm, microcatheter shaping is one of the surgical procedures for the core neck. The traditional manual operation has great limitations, high difficulty, and a long learning cycle for doctors, which are the main pain points that restrict the development and wide-scale popularization of neurointervention.
Without the assistance of intelligent technology, neurologists can only rely on visual recognition to find the best working angle, perform traditional point-to-point “pull-wire” two-dimensional measurements by hand, and perform first-level microcatheter shapes in their minds based on personal experience. The curved two-dimensional plane design, and the operator can only perform the shaping of the shaping needle and the microcatheter, and the delivery of the microcatheter without any auxiliary guidance.
In addition, the traditional aneurysm interventional surgery techniques and experience cannot be standardized and replicated. Patients and operators are concentrated in the head hospital, and it is difficult to sink to the grassroots level, resulting in a serious imbalance between the supply and demand of brain surgery.
Based on these pain points, UKnow® can provide automatic measurement of various three-dimensional morphological parameters of cerebral blood vessels, including key parameters such as aneurysm long diameter, transverse diameter, width, height, volume, incident angle, aneurysm neck diameter, parent artery diameter, etc. Help doctors accurately understand the anatomy of the lesion. A real-world study of this 3D automatic measurement algorithm showed that its accuracy, consistency, and repeatability were significantly better than 2D manual measurements.
Secondly, UKnow® provides intelligent and visualized path planning and guidance of microcatheters and shaping needles, and provides individual shaping solutions based on the physical characteristics of different brands of microcatheters and the anatomical features of the patient’s lesions. Intraoperative shaping and delivery.
Combined with the UMate-Shape® plastic needle automatic forming terminal equipment developed by Qianglian Zhichuang®, it can automatically complete the forming steps of the plastic needle at the core of the operation, and realize the automatic operation plan + automatic intraoperative guidance + automatic operation of all-path intelligent surgery solution.
The clinical research of UKnow® adopts a strict prospective, multi-center, randomized controlled clinical trial design. Catheter delivery and subsequent surgical steps, while the control group (artificial group) was performed by doctors independently of all surgical steps.
The test results showed that the intelligent group was significantly better than the manual group in terms of the success rate of the microcatheter in place for the first time, the success rate of the microcatheter in place within 5 minutes, the time of successful placement, the transportability and stability of the microcatheter. Safety, shortening the time of X-ray radiation for doctors and patients during surgery, and reducing surgical complications.
Statistical analysis of groups of doctors with different surgical experience shows that UKnow® surgery planning software is significantly beneficial to surgeons with less independent surgical experience. Doctors with less than five years of independent surgical experience, with the assistance of intelligent software, have a successful rate from 50% increased to 94%.
Doctors with more independent surgical experience deal with relatively more complex aneurysms. The personalized surgical plan provided by this product can help operators to challenge more difficult and complex cases, and the success rate has increased from 75% to 96%.
Founded in 2016, Qianglian Zhichuang® is committed to reconstructing the diagnosis and treatment technology of cerebrovascular disease with intelligent means. Since its establishment, Qianglian Zhichuang® has successively conducted cooperative research with the team of Professor Zhang Hongqi of Xuanwu Hospital of Capital Medical University and the team of Professor Gu Yuxiang of Huashan Hospital Affiliated to Fudan University. Leifeng Network Leifeng Network
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